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Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations (PIVKIV)

This study is not yet open for participant recruitment.
Verified September 2012 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01685658
First received: September 12, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

The main objective of this study was to demonstrate the non-inferiority of intravenous paracetamol relative to intravenous ketoprofen when treating renal colic in an emergency ward. Efficacy was measured by the change in visual analog scale for pain at 30 minutes.


Condition Intervention Phase
Renal Colic
Acute Renal Colic
 Drug: Intravenous ketoprofen
Drug: Intravenous paracetamol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Efficacy of Intravenous Paracetamol and Ketoprofen When Treating Renal Colic in Emergency Situations: a Randomized, Double-blind Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Change in visual analog scale for pain [ Time Frame: baseline to 30 minutes ] [ Designated as safety issue: Yes ]
    Visual analog scale ranging from 0 to 10.0.


Secondary Outcome Measures:
  • Change in visual analog scale for pain [ Time Frame: baseline to 90 minutes ] [ Designated as safety issue: Yes ]
    Visual analog scale ranging from 0 to 10.0.

  • Was tramadol administered? yes/no [ Time Frame: baseline (minute 0) ] [ Designated as safety issue: No ]
  • Was tramadol administered? yes/no [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Was tramadol administered? yes/no [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • Was tramadol administered? yes/no [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ] [ Designated as safety issue: No ]
  • Was phloroglucinol administered? yes/no [ Time Frame: baseline (minute 0) ] [ Designated as safety issue: No ]
  • Was phloroglucinol administered? yes/no [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Was phloroglucinol administered? yes/no [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • Was phloroglucinol administered? yes/no [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ] [ Designated as safety issue: No ]
  • Was morphine administered? yes/no [ Time Frame: baseline (minute 0) ] [ Designated as safety issue: No ]
  • Was morphine administered? yes/no [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Was morphine administered? yes/no [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • Was morphine administered? yes/no [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ] [ Designated as safety issue: No ]
  • Presence/absence of complications [ Time Frame: baseline (minute 0) ] [ Designated as safety issue: Yes ]
    cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine

  • Presence/absence of complications [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine

  • Presence/absence of complications [ Time Frame: 90 minutes ] [ Designated as safety issue: Yes ]
    cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine

  • Presence/absence of complications [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ] [ Designated as safety issue: Yes ]
    cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine

  • Presence/absence of complications [ Time Frame: week 1 ] [ Designated as safety issue: Yes ]
    cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine


Estimated Enrollment: 236
Study Start Date: December 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketaprofen

Patients randomized to this arm will receive intravenous ketaprofen when treating renal colic.

Intervention: intravenous ketaprofen

 Drug: Intravenous ketoprofen
Patients will recieve 100 mg of ketoprofen via slow intravenous perfusion. (100mg of ketoprofen powder for injection dissolved in 100 ml injectable isotonic solution)
Experimental: Paracetamol

Patients randomized to this arm will receive intravenous paracetamol when treating renal colic.

Intervention: intravenous paracetamol

 Drug: Intravenous paracetamol
Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)

Detailed Description:

The secondary objectives of this study are:

  • To compare the efficacy (non-inferiority) of intravenous paracetamol and ketoprofen at 90 minutes (visual analog scale for pain).
  • To compare both arms in terms of other administered drugs (for pain).
  • To observe and compare side effects between the two arms: cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine.
  • To determine predictors for the use of intravenous morphine when treating renal colic.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for a telephone interview at week 1
  • Patient consulting at the Nîmes University Hospital emergency ward with suspicion of renal colic

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • The patient has a contraindication for a treatment used in this study
  • The patient is allergic to paracetamol or ketoprofen
  • The patient has a fever or is hemodynamically unstable
  • The patient has a history of aneurysm or aortic dissection, history of renal transplantation, history of renal or hepatic insufficiency
  • The patient took paracetamol or ketoprofen 4 hours before treating emergencies.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685658

Contacts
Contact: Pierre-Géraud Claret, MD +33.(0)4.66.68.80.83 pierre.geraud.claret@gmail.com
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Not yet recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Pierre-Géraud Clarey, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Pierre-Géraud Claret, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01685658     History of Changes
Other Study ID Numbers: LOCAL/2012/PGC-01, 2012-003994-24
Study First Received: September 12, 2012
Last Updated: September 12, 2012
Health Authority: France: L’Agence nationale de sécurité du médicament et des produits de santé
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Emergencies
Renal Colic
Colic
Disease Attributes
Pathologic Processes
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Acetaminophen
Ketoprofen
Antipyretics
Physiological Effects of Drugs
 Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013